MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-3023-XX

Device Problems Component Missing (2306); Out-Of-Box Failure (2311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per sop 01-061 since the serial number for the unit was not provided.A getinge representative reported that there was no alleged malfunction of the iabp, and that the event complaint was solely for empty helium cylinders.

Event Description

The customer reported that the staff in icu/ccu tried on three occasions to swap the helium cylinder on their cs300 intra-aortic balloon pump (iabp) while it was in use on a patient.On all three of these occasions full unwrapped cylinders were attempted to mount on the iabp.On all three occasions it was noted that these new previously unwrapped cylinders were empty.On examination of these cylinders by a getinge representative, it was noticed that all three cylinders were completely empty of helium to the extent that there was no pressure at all in any of these cylinders.The staff involved in this complaint were all experienced nurses who have experience with the cs300 and have been trained on its use.Staff was required to source a full helium cylinder from an adjacent hospital.The three empty helium cylinders have been quarantined by staff and handed to the getinge representative for investigation.This event occurred while the iabp was in use on a patient.No adverse event has been reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6737050
• MDR Text Key: 81072613
• Report Number: 2249723-2017-00135
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3023-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1